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Testosterone Therapy in Hypogonadal Men Treated With Opioids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02433730
Recruitment Status : Unknown
Verified April 2018 by Marianne Andersen, Odense University Hospital.
Recruitment status was:  Recruiting
First Posted : May 5, 2015
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
Marianne Andersen, Odense University Hospital

Tracking Information
First Submitted Date  ICMJE January 27, 2015
First Posted Date  ICMJE May 5, 2015
Last Update Posted Date April 4, 2018
Study Start Date  ICMJE May 2015
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2015)
lean body mass [ Time Frame: 24 weeks ]
dual xray absorptiometry scan
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Testosterone Therapy in Hypogonadal Men Treated With Opioids
Official Title  ICMJE The Effect of Testosterone Replacement in Patients With Hypogonadotrophic Hypogonadism Due to Opioid Treatment for Non-malignant Disease
Brief Summary

The purpose of this study is to evaluate the efficacy of testosterone replacement therapy in men with low testosterone due to opioid treatment on body composition, the haemostatic system, glucose metabolism, muscle function, pain sensitivity, pain modulation, lipids, sexual function and quality of life.

Male patients on opioids for non-malignant diseases aged 18-59 years diagnosed with hypogonadotrophic hypogonadism, referred from day hospitals and outpatient populations. 40 patients are randomized to either testosterone undecanoate i.m. or placebo i.m., i.e. 20 patients per arm

A double blinded randomized placebo controlled trial

Detailed Description

The study duration is 24 weeks. Patients are treated with Testosterone Undecanoate 1000 mg/4 ml, intramuscular (i.m.) or placebo at 0, 6 and 18 weeks.

Outcome measures will be evaluated at 0 and 14 weeks.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hypogonadism
Intervention  ICMJE
  • Drug: Testosterone
    intramuscular injection
    Other Name: nebido
  • Drug: placebo
    intramuscular injection
Study Arms  ICMJE
  • Active Comparator: placebo
    intramuscular injection
    Intervention: Drug: placebo
  • Active Comparator: testosterone
    intramuscular injection
    Intervention: Drug: Testosterone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 29, 2015)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male patients 18-75 years
  • Treatment with opioid for >3 months, daily dose >50-100 mg
  • Total testosterone < 12 mmol/L
  • Follicle Stimulating Hormone (FSH)/Luteinizing Hormone (LH) levels normal og below normal laboratory values
  • Normal prolactin levels

Exclusion Criteria:

  • Hematocrit> 54% at screening
  • Prostate Specific Antigen (PSA) > 3 ng/ml
  • Severe organic and mental disease
  • current or present cancer diagnosis
  • Previous venous thrombotic embolism and cerebrovascular disease
  • Uncontrolled hypertension
  • Epilepsy or migraine not adequately controlled by therapy
  • Severe benign prostate hypertrophy with symptom score >19
  • Sleep apnea
  • Alcohol or drug abuse
  • Implantation of sustained action sex hormone in the last 12 months
  • Use of oral, buccal or transdermal testosterone in the last two weeks
  • Treatment with glucocorticoids > 5 mg/day or 5 alfa reductase inhibitors
  • Hypersensitivity to Nebido
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02433730
Other Study ID Numbers  ICMJE 22102014
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marianne Andersen, Odense University Hospital
Study Sponsor  ICMJE Marianne Andersen
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Odense University Hospital
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP